Clinical Evaluation of CATS Tonometer Prism
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/24/2018 |
| Start Date: | January 2017 |
| End Date: | October 2018 |
Prospective, open-labeled, randomized, controlled, multicenter study at two clinical
investigative sites in Tucson, Arizona. The subjects will undergo intraocular pressure
measurement with the CATS tonometer prism and the Goldmann applanation tonometer prism (GAT).
Seventy-five (75) Subjects 18 and older and will be enrolled. Subjects will be screened based
on standard of care vision examination at the clinical investigation sites. All subjects will
undergo a standard ophthalmic exam and informed consent. IOP will be measured using a
Goldmann tonometer armature with both the standard flat GAT prism and the modified curved
CATS prism alternately inserted. The only additional measurement is central corneal thickness
(CCT) which is used to correct for one of the corneal biomechanical errors seen in the GAT
prism and is currently standard of care.
investigative sites in Tucson, Arizona. The subjects will undergo intraocular pressure
measurement with the CATS tonometer prism and the Goldmann applanation tonometer prism (GAT).
Seventy-five (75) Subjects 18 and older and will be enrolled. Subjects will be screened based
on standard of care vision examination at the clinical investigation sites. All subjects will
undergo a standard ophthalmic exam and informed consent. IOP will be measured using a
Goldmann tonometer armature with both the standard flat GAT prism and the modified curved
CATS prism alternately inserted. The only additional measurement is central corneal thickness
(CCT) which is used to correct for one of the corneal biomechanical errors seen in the GAT
prism and is currently standard of care.
Inclusion Criteria:
- Written informed consent (and assent when applicable) obtained from subject or
subject's legal representative and ability for subject to comply with the requirements
of the study.
- Male and female patients, at least 18 years of age
Exclusion Criteria:
- Subject has undergone ocular surgery within the last 3 months
- Uncontrolled systemic disease that in the opinion of the Investigator would put the
subject's heath at risk
- Pregnant or nursing women
- Subjects with only one functional eye
- Those with one eye having poor or eccentric fixation
- Eyes displaying an oval contact image
- Those with corneal scarring or who have had corneal surgery including corneal laser
surgery
- Microphthalmos
- Buphthalmos
- Contact lens wearers
- Severe Dry eyes
- Lid squeezers - blepharospasm
- Nystagmus
- Keratoconus
- Any other corneal or conjunctival pathology or infection.
- Central corneal thickness between 0.600 mm and 0.500 mm (more than 2 standard
deviations about the human mean)
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